BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC ONE (SYNVISC ONE)

    MDR report key: 3842663 · Received May 16, 2014

    Report

    Report Number
    2246315-2014-58848
    Event Type
    Injury
    Date Received
    May 16, 2014
    Date of Event
    April 29, 2014
    Report Date
    May 5, 2014
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PHARMACOVIGILANCE COMMENT: SANOFI COMPANY COMMENT DATED (B)(6)-2014: IN THIS CASE THE PT DEVELOPED GRAM POSITIVE BACTERIA IN KNEE LIQUID ARTHROCENTESIS AFTER TREATMENT WITH SYNVISC ONE. ALTHOUGH THE ROLE OF DRUG CANNOT BE EXCLUDED FOR THE OCCURRENCE OF THE EVENT; HOWEVER LACK OF DETAILED INFO REGARDING THE CONCOMITANT DRUGS OR PAST MEDICAL DRUGS PRECLUDES A COMPREHENSIVE ASSESSMENT OF THE CASE.

    Description of Event or Problem · 1

    THIS UNSOLICITED DEVICE CASE WAS RECEIVED FROM (B)(6) ON (B)(6)-2014 FROM A PHYSICIAN (RHEUMATOLOGIST) VIA SALES REP. THIS CASE CONCERNS A 94 YEAR OLD MALE PT WHO WAS PRESENTED WITH GRAM POSITIVE BACTERIA IN KNEE LIQUID ARTHROCENTESIS, SEVERE LEFT KNEE PAIN AND SEVER LEFT KNEE INFLAMMATION AFTER RECEIVING TREATMENT WITH SYNVISC-ONE INJECTION AND PT ALSO COMPLAINED OF IMPOSSIBILITY TO WALK. THE PT'S MEDICAL HISTORY WAS SIGNIFICANT FOR OSTEOARTHRITIS WITH SEVERAL YEAR OF EVOLUTION, PREVIOUSLY TREATED WITH SEVERAL UNSPECIFIED DRUGS. THE CONCURRENT CONDITION INCLUDED CARDIAC ARRHYTHMIA (WITH SEVERAL YEARS OF EVOLUTION, IN TREATMENT WITH SEVERAL UNSPECIFIED DRUGS); ANEMIA, RENAL FAILURE AND HIGH HEPATIC ENZYMES (WITH 02 YEARS OF EVOLUTION SINCE 2012, IN TREATMENT WITH SEVERAL UNSPECIFIED DRUGS) AND ALZHEIMER'S DISEASE IN TREATMENT WITH ORAL UNSPECIFIED DRUG. THE PAST DRUGS ALLERGIES AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON (B)(6)-2014, THE PT RECEIVED TREATMENT WITH INTRA-ARTICULAR SYNVISC-ONE INJECTION, AT A DOSE OF 6 ML, ONCE (BATCH/LOT NUMBER AND EXPIRATION DATE UNK) IN THE LEFT KNEE FOR OSTEOARTHRITIS. ON (B)(6)-2014 (01 DAY AFTER RECEIVING TREATMENT WITH SYNVISC-ONE), THE PT PRESENTED WITH SEVERE LEFT KNEE PAIN AND INFLAMMATION WHICH CAUSED IMPOSSIBILITY TO WALK. ON (B)(6)-2014, THE PT VISITED ANOTHER RHEUMATOLOGIST AND KNEE ARTHROCENTESIS WAS PERFORMED (UNK AMOUNT OF FLUID ASPIRATED), WHICH SHOWED NORMAL RESULTS. ON (B)(6)-2014 (05 DAY AFTER RECEIVING TREATMENT WITH SYNVISC-ONE), THE PT AGAIN VISITED RHEUMATOLOGIST AS THE EVENTS WERE PERSISTED. THE PHYSICIAN PERFORMED A JOINT LAVAGE AND ANOTHER KNEE ARTHROCENTESIS WHICH SHOWED GRAM POSITIVE BACTERIA IN KNEE FLUID ARTHROCENTESIS; THEREFORE FROM (B)(6)-2014, THE PT WAS HOSPITALIZED. CORRECTED TREATMENT: LEFT KNEE PAIN AND LEFT KNEE INFLAMMATION: JOINT LAVAGE AND KNEE ARTHROCENTESIS FOR TWO TIMES; NOT REPORTED FOR REST OF THE EVENTS. OUTCOME: LEFT KNEE PAIN AND LEFT KNEE INFLAMMATION: NOT YET RECOVERED. IMPOSSIBILITY TO WALK AND GRAM POSITIVE BACTERIA IN KNEE LIQUID ARTHROCENTESIS: UNK. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED WITH GLOBAL PTC NUMBER: (B)(4) AND CONCLUSION WAS PENDING FOR THE SAME. SERIOUSNESS ASSESSMENT: LEFT KNEE PAIN AND LEFT KNEE INFLAMMATION: SERIOUS (PERSISTENT AND SIGNIFICANT DISABILITY/INCAPACITY AND REQUIRED INTERVENTION). GRAM POSITIVE BACTERIA IN KNEE LIQUID ARTHROCENTESIS: SERIOUS (INPATIENT/PROLONGED HOSPITALIZATION). NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293148 SYNVISC ONE (SYNVISC ONE) INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Hospitalization| S CON MEDS = UNK| PREV MEDS = UNK